Clinical trial · Interventional
Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain
A Phase I Study Of Seven Day Continuous Intrathecal/Intraventricular Infusion Of Topotecan For Patients With Recurrent, Progressive Or Refractory Leptomingeal Disease
NCT00025311CI-TRIAL-00008463completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of intrathecal or intraventricular topotecan in treating recurrent, progressive, or refractory cancer that is metastatic to the lining around the brain.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologic or tumor marker confirmation of malignancy at original diagnosis
* Neoplastic meningitis/leptomeningeal metastasis refractory to conventional therapy and other therapies of higher priority, defined as:
* Stratum A:
* Small non-cleaved lymphoma (Burkitt's) with any L-3 blast in cerebrospinal fluid (CSF)
* Any other lymphoma or leukemia with CSF cell count greater than 5/mm3 AND evidence of blast cells by cytology or cytospin preparation OR
* Stratum B:
* Solid tumor or other malignancy with presence of tumor cells on cytospin OR positive cytology OR neuroimaging evidence of leptomeningeal tumor by MRI or CT myelogram
* No leptomeningeal leukemia or lymphoma with concurrent bone marrow relapse
* No clinical evidence of untreated obstructive hydrocephalus or compartmentalization of the CSF
PATIENT CHARACTERISTICS:
Age:
* 65 and under
Performance status:
* Lansky 50-100% (age 16 and under)
* Karnofsky 50-100% OR ECOG 0-3 (over age 16)
Life expectancy:
* At least 2 months
Hematopoietic:
* Stratum B:
* Absolute neutrophil count at least 750/mm\^3
* Platelet count at least 75,000/mm\^3 (transfusion independent)
* Hemoglobin at least 10.0 g/dL (red blood cell transfusions allowed)
Hepatic:
* Bilirubin no greater than 1.5 times normal
* SGOT or SGPT less than 2.5 times upper limit of normal
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Neurologic:
* Seizures allowed if well controlled and on anticonvulsants
* CNS toxicity no greater than grade 2
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled infections
* HIV allowed
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent immunomodulating agents (stratum B)
* No stem cell transplantation (stratum A)
Chemotherapy:
* At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas)
* No other concurrent cancer chemotherapy (stratum B)
* Other concurrent systemic cancer chemotherapy for leukemia or lymphoma allowed with the following restrictions:
* No oral or IV topotecan
* No moderate or high-dose IV or subcutaneous cytarabine (greater than 1.0 g/m2 per day)
* No moderate or high-dose IV methotrexate (greater than 1 g/m2 per day)
* No IV thiotepa
* No myeloablative chemotherapy
* No intrathecal or intraventricular chemotherapy
Endocrine therapy:
* Concurrent corticosteroids allowed only for treatment of increased intracranial pressure in patients with CNS tumors
* No concurrent intrathecal or intraventricular hydrocortisone
Radiotherapy:
* At least 4 weeks since completion of radiotherapy to the brain or spine and recovered
* Concurrent radiotherapy to localized painful lesions producing acute neurologic dysfunction allowed provided at least 1 measurable lesion is not irradiated
* No concurrent craniospinal or whole-brain radiotherapy
Surgery:
* Not specified
Other:
* Recovered from prior therapy
* At least 7 days since prior investigational drug
* No other concurrent intrathecal or intraventricular therapy for leptomeningeal diseaseReferences
Publications (0)
Data not yet available
No reference posted for this study.